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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05540730
Other study ID # IstanbulMUH-DPTR-Yozdemir-0094
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 3, 2019
Est. completion date December 1, 2022

Study information

Verified date September 2022
Source Istanbul Medipol University Hospital
Contact Yunus Özdemir, MSc
Phone +905423768488
Email yozdemir@medipol.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to investigate the foot plantar pressure behavior alterations during gait for children with obstetric brachial plexus (OBBP). 19 children with OBBP and 10 healthy children will be included in the study. The inclusion criteria of the study were to be between the ages of 7-15, not have a history of surgery or botox in the last 6 months, and not have any other disease. Foot plantar pressures of all participants will be analyzed with a pedobarography device. For arm swing analysis, a video camera will be recorded during walking and arm flexion/extension angles will be measured with Kinovea software.


Recruitment information / eligibility

Status Recruiting
Enrollment 29
Est. completion date December 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 15 Years
Eligibility Inclusion Criteria: - Between the ages of 7-15. No other disease Exclusion Criteria: - Having undergone surgery or botox intervention for orthopedic problems in the last 6 months. Having health problems in the unaffected extremity or adversely affecting general body health. The participant's parent has not signed the consent form.

Study Design


Intervention

Diagnostic Test:
Gait Analysis
Foot plantar pressure with pedobarography and arm swing with video camera will be analyzed.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stance Time stance time phase during walking during gait analysis.
Secondary Step Length during gait analysis.
Secondary Ground reaction force during gait analysis.
Secondary Single limb support phase Single limb support phase during walking during gait analysis.
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